The invention relates generally to medical surgical devices, and more particularly to a device and method of stabilizing a surgical site during cardiac or cardiovascular surgery.
Heart disease and associated cardiovascular problems have become so common in the United States that over 400,000 open heart surgeries are performed each year. Traditionally, physicians would open the chest and stop the heart before performing a surgical procedure on the heart. However, medical practices have improved, and physicians now recognize that there are advantages to performing surgery on a beating heart. For example, performing surgery on a beating heart avoids the necessity to expose the heart to filters, oxygenators, tubes, and other devices. This decreases the trauma associated with stopping the heart, as well as avoids other dangers that stopping the heart poses to a patient. In addition, by avoiding the use of these devices, the physician can lower the expense of an operation. Furthermore, performing surgery on a beating heart lowers the risk of ischemic damage to heart and surrounding tissue.
Unfortunately, there are many difficulties and challenges which must be overcome to successfully perform surgery on a beating heart. For example, every time the heart beats, the heart moves. This makes it difficult to isolate a specific site on the heart for surgery. Furthermore, physicians typically must develop great skill and expertise to accommodate the movement of the heart with existing instruments which were designed for use with a heart that is stopped. Because of the increased demands of performing surgery on a beating heart, surgery on a beating heart often takes longer than surgery on a stopped heart. Fortunately, devices and methods are being developed which decrease the amount of time and expertise it takes to identify and isolate a target vessel and thus, reduce the time it takes to perform open heart surgery.
One family of instruments which have been developed to facilitate surgery on a beating heart are known as cardiac immobilization devices or heart stabilizers (devices). A number of these devices function by attaching to the heart at two or more points. The points are then moved further apart, thus stretching the surface area of the heart about which surgery is to be performed (surgical site). The devices typically grip the heart surface by suction. Unfortunately, there are a number of disadvantages associated with these methods of isolating a surgical site.
Some cardiac immobilization devices often appear to be little more than steak tongs or clamps which have been slightly altered to attach to a heart surface. Other devices use flex links or rods to attach to a retractor and then use a metallic foot to stabilize the heart surface. Suction devices may comprise a plurality of suction cups, or may have at least one hollow cylinder with holes in it, which is then attached to a pump which pulls a vacuum at the holes.
FIG. 1A (prior art) shows a cardiac immobilization device 130 attached to a heart surface 140. To perform open heart surgery, typically a chest retractor 110 is braced within a rib cage and used to maintain an opening in the chest wall 112 which provides access to the heart surface 140. A stabilizing member, such as a flexible arm assembly 120 is used to securely locate a cardiac immobilization device 130 upon the heart surface 140. Accordingly, the stabilizing member 120 is coupled to the retractor 110 via a clamp 126 and holds the cardiac immobilization device 130 in a predetermined position.
The flexible arm assembly 120 includes a flexible arm 124 which may be bent and twisted into various shapes and geometries to access different locations on the heart surface 140. At the end of the flexible arm 124 closest to the heart surface 140 is a socket 128 for attaching the flexible arm 124 to the cardiac immobilization device 130. At the other end of the flexible arm 124 is a handle 122 which when turned tightens a cable (not shown) within the flexible arm 124. The tightening of the cable makes the flexible arm 124 rigid and immobile. The tightening of the cable also tightens the socket 128, allowing the socket 128 to grip an object, such as a ball 132 (the ball 132 is part of the cardiac immobilization device 130).
The shown cardiac immobilization device 130 uses suction to attach to a surface of the heart 140. To attach the cardiac immobilization device 130 to the heart surface 140, the cardiac immobilization device 130 utilizes a foot plate 136 with holes thereunder (not shown) on which a vacuum is placed. The vacuum is maintained by air hoses 134 which are attached to an air pump (not shown) and the foot plate 136. Thus, the cardiac immobilization device 130 is held stationary on the heart surface 140 at the end of the flexible arm 124 of the flexible arm assembly 120 so that the heart surface 140 located within the foot plate 136 can be isolated.
One disadvantage of many tong type attachments is that they provide an uneven spread (the heart surface closest to the tong""s hinge point is spread a smaller distance than the heart surface at the end of the tong).
There are also many disadvantages associated with using suction to isolate a surgical site. For example, many patients have a heart which is surrounded with fatty tissue. Since the fat surrounding the heart moves, when a physician uses a suction device to isolate a heart surface, the suction cups or suction holes attach to the fat (rather than the heart surface). The operative result of the device attaching to the fatty tissue is that the heart surface can still beat underneath the fatty tissue, which means that isolation and stabilization of the surgical site is poor. Furthermore, the fatty tissue may be drawn into the device (at a hole, for example) by the suction, and may clog the suction device thereby stopping suction at the holes which are further along and at the end of the device. In addition, after attachment to the heart is made with a suction device, the ability to spread the heart surface is limited by the force of suction on the heart surface. Should the suction break, the device must be repositioned and reattached to the heart, which consumes time and is a nuisance to the physician. Furthermore, when strong enough suction is applied to the heart surface to achieve adequate spreading and to prevent slippage, the suction can cause blood to accumulate and clot just beneath the heart surface, a hematoma (this condition is also commonly referred to as a xe2x80x9cheart hickiexe2x80x9d).
Therefore, what is needed is a device and method of isolating a surgical site for cardiac and cardiovascular surgery. The device should contact a minimal surface of the heart, accommodate the non-planar geometry of the heart, grip the heart firmly, yet gently, and should be easy to apply to and to remove from a beating heart. The present invention provides such a device and method.
Blood in arteries can spew out from the anastomosis site during surgery, which reduces visualization for the surgeon. Periodically, blood must be manually removed by an assistant typically with a blower. The surgeon, therefore, must stop the procedure so that blood can be removed. What is needed, therefore, is a stabilization device integral with a blower device so that the blower could be operated remotely without interfering with the procedure.
The present invention provides a device and method for isolating a heart surface, particularly, the surface of a beating heart during cardiovascular surgery. The device utilizes rotation to attach to the heart surface and then spread the heart which isolates the spread portion of the heart for surgery.
Disclosed is a device for isolating a cardiac surgical site. The device generally comprises a first finger (which may be cylindridal) having a clinging accessory for attaching the first finger to a heart. Furthermore the device could comprise a second finger having a clinging accessory for attaching the second finger to the heart, a first joint disposed on the first finger so that the first finger may rotate on a surface of the heart such that said rotation stretches a surgical site, and a link for attaching the first finger to the second finger. In addition, a first stopper may be disposed on the first finger for preventing undesired rotation of the first finger to isolate the surgical site.
The accessory for attaching could comprise a plurality of tines, a plurality of suction points, or a rough textured surface such as a surface similar to sandpaper, for example. In addition, the first joint or a second joint (disposed on the second finger) could comprise a rotatable handle coupled in a sleeve. Furthermore, the first stopper or a second stopper (disposed on the second finger) could be configured such that the rotatable handle comprises at least one notch and the sleeve has at least one rib. Likewise, the first stopper or the second stopper (disposed on the second finger) could be configured such that the rotatable handle comprises at least one rib and the sleeve has at least one notch. The handle could comprise an O-ring groove for securing an O-ring about an end of the handle.
The link could comprise a ball and socket joint disposed between the first finger and the second finger for providing multi-axis articulation of the first finger and the second finger, as well as a first attachment bar coupled between the first handle and the ball and socket joint, and a second attachment bar coupled between the second handle and the ball and socket joint. Conversely, the link could comprise a first ball and socket joint associated with the first handle, a second ball and socket joint associated with the second handle, and an attachment bar for coupling the first ball and socket joint to the second ball and socket joint.
More generally, the present invention provides a means for isolating a cardiac surgical site. The means for isolating comprises a first support means, such as a finger or a functional equivalent, having a clinging means for attaching the first support means to a heart, and a second support means, such as a second finger or a functional equivalent, having a clinging means for attaching the second support means to the heart. The means for isolating also includes a rotating means, such as a cylinder or a functional equivalent, disposed on the first support means so that the first support means may rotate on a surface of the heart, a locking means, such as a rib and notch, or a functional equivalent, disposed on the first support means for preventing undesired rotation of the first support means. An attaching means, such as a link or a functional equivalent, connects the first support means to the second support means.
There is also provided a shield or guard attached to the fingers so the clinging means will not catch sutures, gloves or tissues during the medical procedure. The shield may also have a sprayer for washing the surgical site.
In another embodiment, the present invention provides a method of isolating a cardiac surgical site. The method comprises disposing a first finger on a heart, clinging the first finger to the heart surface, disposing a second finger on a heart, clinging the second finger to the heart surface, and rotating the first finger for achieving selective isolation of cardiac tissue. The method may further comprise rotating the second finger, locking the first finger to prevent rotation, or locking the second finger to prevent rotation. The method may also provide that clinging comprises penetrating the surface of the heart, applying suction to the surface of the heart, or applying an abrasive surface for frictionally gripping the surface of the heart. In addition, when applying a finger, the method may further comprise the step of compressing the finger onto the heart surface. Furthermore, the method could include the step of elevating the finger while maintaining its attachment to the heart surface.
The rotational action of the present invention allows the physician to overcome problems associated with fatty tissue on the heart surface, to adjust the spread of the heart surface during surgery, and to attach and detach the present invention from the heart quickly.